Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06307457
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-03-05
Brief Title:
A Study of HRHER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Impact of Age and Comorbidities on Treatment Outcomes of First-line Treatment With Palbociclib in Combination With an Aromatase Inhibitor AI in Patients Diagnosed With HRHER2 - Metastatic Breast Cancer - Danish Non-Interventional Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer The study will consider participants who
have advanced or metastatic breast cancer that is spread to other parts of the body
have HRHER2- hormone receptor positive human epidermal growth factor receptor 2 negative breast cancer types
Hormone receptor positive HR are cells that have a group of proteins that bind to a specific hormone For example some breast cancer cells have receptors for the hormones estrogen or progesterone
These cells are hormone receptor positive and they need estrogen or progesterone to grow This can affect how the cancer is treated Knowing if the cancer is hormone receptor positive may help plan treatment
Human epidermal growth factor receptor 2 negative HER2- cells that have a small amount or none of a protein called HER2 on their surface In normal cells HER2 helps control cell growth Cancer cells that are HER2 negative may grow more slowly and are less likely to recur come back or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface Checking to see if a cancer is HER2 negative may help plan treatment
have started treatment in the period between January 2017 and December 2021
The study will describe the treatment effect for different patient groups in terms of age and comorbidities Comorbidity is the condition of having two or more diseases at the same time The data is collected by the Danish Breast Cancer Group in the period between 2017 to 2023
have advanced or metastatic breast cancer that is spread to other parts of the body
have HRHER2- hormone receptor positive human epidermal growth factor receptor 2 negative breast cancer types
Hormone receptor positive HR are cells that have a group of proteins that bind to a specific hormone For example some breast cancer cells have receptors for the hormones estrogen or progesterone
These cells are hormone receptor positive and they need estrogen or progesterone to grow This can affect how the cancer is treated Knowing if the cancer is hormone receptor positive may help plan treatment
Human epidermal growth factor receptor 2 negative HER2- cells that have a small amount or none of a protein called HER2 on their surface In normal cells HER2 helps control cell growth Cancer cells that are HER2 negative may grow more slowly and are less likely to recur come back or spread to other parts of the body than cancer cells that have a large amount of HER2 on their surface Checking to see if a cancer is HER2 negative may help plan treatment
have started treatment in the period between January 2017 and December 2021
The study will describe the treatment effect for different patient groups in terms of age and comorbidities Comorbidity is the condition of having two or more diseases at the same time The data is collected by the Danish Breast Cancer Group in the period between 2017 to 2023
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None